SPIROMICS GIC Support

SPIROMICS GIC 支持

• 批准号: 9762969
• 负责人: David J Couper
• 金额: $ 145.51万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762969
• 关键词: Applications Grants; Biological; Blood; Bronchoscopy; Budgets; Cause of Death; Chronic Obstructive Airway Disease; Clinic Visits; Clinical; Clinical Investigator; Clinical Trials; Cohort Studies; Contracts; Data; Development; Diagnostic radiologic examination; Disease Progression; Enrollment; Ensure; Federal Government; Foundations; Funding; Future; Genomics; Grant; Incentives; Informatics; Informed Consent; Infrastructure; Institutional Review Boards; Length; Longitudinal Studies; Maintenance; Manuscripts; Medical; Methods; Monitor; National Heart, Lung, and Blood Institute; Observational Study; Outcome; Outcome Measure; Participant; Pathway interactions; Patients; Phenotype; Policies; Procedures; Process; Property; Publishing; Reporting; Research Personnel; Sampling; Schedule; Science; Serious Adverse Event; Ships; Smoker; Specimen; Spirometry; Sputum; Statistical Data Interpretation; Subgroup; Symptoms; System; Telephone; Therapeutic Trials; Time; Validation; Visit; X-Ray Computed Tomography; adjudication; aged; base; clinical research site; cohort; data management; disease phenotype; expectation; follow-up; improved; interest; meetings; mortality; never smoking; non-smoker; novel; operation; preservation; symposium; targeted treatment; web site

SPIROMICS GIC ABSTRACT This application proposes infrastructure support for the Genomics and Informatics Center (GIC) and assistance to the clinical sites and investigators for the multi-center Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). SPIROMICS I enrolled a cohort of 2,981 participants aged 40-80, including non-smokers and smokers with or without COPD. Data, CT images and biospecimens were collected at study visits and participants had quarterly telephone contacts, which are ongoing. A grant application to continue the study as SPIROMICS II has been reviewed and received a fundable priority score. SPIROMICS II will include an additional clinic visit and continued telephone follow-up. Because SPIROMICS I was funded through contracts from NHLBI, the biospecimens and data are the property of the federal government and NHLBI has a vested interest in ensuring that they are stored and managed appropriately. NHLBI is also committed to the science being undertaken in SPIROMICS and thus to maintaining contact with participants and supporting statistical analysis for manuscripts and the infrastructure for the study. The GIC proposes to continue to manage SPIROMICS data and biospecimens, undertake statistical analyses of study data, collaborate in operational and scientific aspects of the study, and provide study management and regulatory oversight. Our principal contributions to the study are grouped into the following specific aims:  Aim 1: Maintenance and management of biospecimens. Ensure specimens are stored under appropriate conditions, manage the process of requesting use of specimens, and pull and ship specimens to investigators when approved by the Steering Committee and NHLBI.  Aim 2: Study management and operational support. Schedule and facilitate meetings and conference calls, support study committees, oversee SPIROMICS policies and procedures, maintain a web site for the study, support continued contact with study participants, including by providing incentives to participants for completion of follow-up telephone calls, continue support for abstraction and adjudication of study endpoints, and provide improved systems for maintenance of CT images.  Aim 3: Data management and statistical support. Manage and distribute study data and conduct statistical analyses for manuscripts and presentations.  Aim 4: Regulatory oversight. Track IRB approvals, manage reporting of serious adverse events, ensure use of data and specimens is in accordance with each participant's informed consent, and report on study progress to the Observational Study Monitoring Board (OSMB). The GIC was responsible for most of these activities in SPIROMICS I. Funding this application will enable us to expand our support for the study, to upgrade procedures, particularly the data management system, and to increase capacity in terms of undertaking statistical analyses for manuscripts.

Spiromics GIC摘要 该申请建议为基因组学和信息学中心（GIC）提供基础设施支持， 向临床研究中心和研究者提供多中心亚群和中间结局指标 COPD研究（SPIROMICS）。SPIROMICS I招募了2，981名年龄在40-80岁之间的参与者，包括 非吸烟者和吸烟者（有或无COPD）。在研究中收集数据、CT图像和生物标本 访问和与会者每季度进行电话联系，这种联系仍在进行。申请资助以继续 SPIROMICS II研究已经过审查，并获得了可资助的优先评分。SPIROMICS II将包括 额外的门诊访视和持续的电话随访。因为我的资金来源是 根据NHLBI的合同，生物标本和数据是联邦政府的财产，NHLBI拥有 确保它们得到妥善储存和管理的既得利益。NHLBI还致力于 因此，与参与者保持联系并支持 手稿的统计分析和研究的基础设施。 GIC建议继续管理SPIROMICS数据和生物标本，进行统计分析， 研究数据，在研究的操作和科学方面进行合作，并提供研究管理 和监管监督。我们对该研究的主要贡献可分为以下具体目标： 目标1：生物标本的维护和管理。确保样本储存在 适当的条件，管理请求使用标本的过程， 经指导委员会和NHLBI批准后，向研究者提供标本。 目标2：研究管理和运营支持。安排和便利会议 电话，支持研究委员会，监督SPIROMICS政策和程序，维护网站， 支持继续与研究参与者接触，包括提供奖励， 参与者完成后续电话，继续支持抽象， 研究终点的判定，并提供用于维护CT图像的改进系统。 目标3：数据管理和统计支助。管理和分发研究数据， 对手稿和报告进行统计分析。 目标4：监管监督。跟踪IRB批准，管理严重不良事件的报告， 确保数据和样本的使用符合每位参与者的知情同意，以及 向观察性研究监查委员会（OSMB）报告研究进展。 GIC负责SPIROMICS I中的大部分活动。资助这项申请将使我们能够 扩大我们对研究的支持，更新程序，特别是数据管理系统，以及 提高对稿件进行统计分析的能力。